SECTion 14 AND 14A NOTICE
I, MAYADA KAYALI, delegate of the Secretary to the Department of Health and Ageing for the purposes of sections 14, 14A and 15 of the Therapeutic Goods Act 1989 (‘the Act’) hereby give my consent, pursuant to sections 14 and 14A of the Act, for Merck Sharp & Dohme (Australia) Pty Limited, Level 4, 66 Waterloo Road NORTH RYDE NSW 2113 to supply the batches of goods listed in the table below that do not comply with subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for medicine labels because their labels do not include the name and address of the current sponsor or supplier of the goods.
Batches of products to which this notice applies
Name of the goods | Batch number(s) |
Aerius 5 mg tablets AUST R 91116 | 1STBAAUA01, 2STBAAEB01 |
Drixine Adult Spray 15 mL AUST R 161596 | 2APMB08A, 2APMB10A |
Drixine No Drip Nasal Spray 15 mL AUST R 166852 | 2E01CP |
Drixine No Drip Moisturising Nasal Spray AUST R 179875 | 2K02ACP |
Drixine No Drip Menthol Nasal Spray AUST R 181889 | 2A03CP |
Children’s Claratyne chewable grape tablets AUST R 169329 | 2HLC4 |
Demazin Cold & Flu tablets AUST R 94036 | BJ382 |
Demazin Cough, Cold & Flu tablets AUST R 97031 | BC835, BM350 |
Demazin Day & Night Cold & Flu tablets AUST R 133205 | BK639 |
Pursuant to section 15(1) of the Act, my consent is subject to the following conditions:
- The products comply with all other aspects of the Therapeutic Goods Order No. 69 – General requirements for medicine label;
2. The product labels include the name and address of the previous sponsor Shering-Plough Pty Ltd; and
3. Merck Sharp & Dohme (Australia) Pty Limited have arranged for any contacts made in relation to the above products to the Shering-Plough Pty Ltd address to be re-directed to the address of the current sponsor.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
1 February 2013
Overview
The Therapeutic Goods Act 1989 was enacted to provide a comprehensive regulatory framework for therapeutic goods in Australia, aiming to ensure that these goods are safe, of high quality, and meet acceptable standards of efficacy. This Act was introduced by the Commonwealth Parliament to address the need for a unified legislative approach to the regulation of therapeutic goods, bridging gaps in previous regulatory frameworks and aiming to protect public health by controlling the supply and use of therapeutic products. The policy objective of the Act is to safeguard public health by ensuring that therapeutic goods available in Australia meet appropriate standards of quality, safety, and efficacy, thereby promoting the optimal therapeutic benefit to consumers. In line with this objective, the Act empowers the Therapeutic Goods Administration to enforce regulations and standards pertaining to the manufacture, importation, supply, and advertising of therapeutic goods.
Scope and Application
The Therapeutic Goods Act 1989 applies to a wide array of entities and individuals involved in the supply, advertising, and representation of therapeutic goods in Australia. This Act governs the regulation of therapeutic goods, including medicines, medical devices, and blood, ensuring their safety, quality, and efficacy. The Act applies to entities such as manufacturers, importers, and sponsors of therapeutic goods, as well as to individuals like health practitioners who supply these goods. Jurisdictionally, the Act operates at the Commonwealth level, with its provisions extending across all states and territories in Australia. Specific exclusions and exemptions are detailed in various sections of the Act and related regulations, with certain goods or categories of goods being subject to different levels of scrutiny or regulatory requirements. The scope of the Act can be further refined through subordinate instruments, which provide detailed guidelines and specific instances of application, ensuring a comprehensive regulatory framework that adapts to the evolving landscape of therapeutic goods.
Key Provisions
The key operative sections of the notice provided by Mayada Kayali, a delegate of the Secretary to the Department of Health and Ageing, pertain to sections 14, 14A, and 15 of the Therapeutic Goods Act 1989 (the Act). Under section 14, the delegate has given consent to Merck Sharp & Dohme (Australia) Pty Limited to supply certain batches of medicinal products that do not comply with subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for medicine labels, specifically because their labels do not include the name and address of the current sponsor or supplier of the goods. This consent is detailed in section 14A of the Act, and it is subject to certain conditions outlined in section 15(1) of the Act.
These conditions include ensuring that the products comply with all other aspects of the Therapeutic Goods Order No. 69, that the product labels include the name and address of the previous sponsor, Schering-Plough Pty Ltd, and that Merck Sharp & Dohme (Australia) Pty Limited have arranged for any contacts related to the above products that are directed to the Schering-Plough Pty Ltd address to be re-directed to the address of the current sponsor. These obligations are crucial to ensuring that the medicinal products meet the required standards and that any necessary information is readily available to consumers and health professionals.
Failure to comply with the conditions stipulated in the notice could result in legal consequences. The Therapeutic Goods Act 1989 includes provisions for both civil and criminal penalties for non-compliance. Civil penalties may include fines, while criminal penalties could result in imprisonment or substantial fines depending on the severity of the breach. The exact penalties are determined by the court and can vary based on the circumstances of the offence. Additionally, non-compliance could lead to further regulatory action, including product recalls or suspension of authorisation, which can have significant implications for the company involved.